---
title: 'BMC Injections for Partial Thickness Rotator Cuff Tears'
type: 'lecture'
url: 'https://doc.social/lectures/bmc-injections-for-partial-thickness-rotator-cuff-tears'
published: '2020-12-05'
author: 'Don Buford, MD, RMSK'
specialty: 'Orthopaedic Surgery'
topics: 'Rotator Cuff, Rotator Cuff Tear, Shoulder, Regenerative Medicine, Sports Medicine, Orthobiologics, Stem Cell, Injection, Rotator, Bone Marrow, Bone Marrow Concentrate'
transcript: 'yes'
---

# BMC Injections for Partial Thickness Rotator Cuff Tears

Bone marrow concentrate (BMC) Injections for partial thickness rotator cuff tears - 2 year results

## Summary

We prospectively treated 25 patients with symptomatic partial thickness rotator cuff tears with an in office bone marrow concentrate injection placed under ultrasound guidance. 2 year follow up results showed durable improvements in pain scores, functional measures, and patient satisfaction. BMC injections are a reasonable treatment alternative for patients with symptomatic partial thickness rotator cuffs tears.

## Transcript

4,630 words · 31 min · automatically transcribed (aws-transcribe) and not checked by a person; it may contain errors, particularly in names, drugs and dosages. The recording is the source.

[0:04] Hello, my name is Doctor Don Buford. I wanna thank the academy for the invitation to uh present at this virtual meeting. Uh, I'm an orthopedic surgeon based in Dallas, Texas. Uh, my contact information is at the bottom. The name of our institute is the Texas Ortho Biologics Institute.
[0:22] Um, and the title of this presentation is Bone Marrow Concentrate Injection for Partial thickness Rotator Cuff tears. We'll run through the, uh, literature to date and then go through our recent work in this, uh, area, uh, trying to, uh, assess whether or not Bone Marrow Concentrate injections make clinical sense and, and give us, uh, reasonable results for Partial-thickness rotator cuff tear patients.
[0:46] These are my academy disclosures.
[0:49] All of these are available online at any time through AAOS.
[0:54] These are my Social Media disclosures.
[0:59] And this is the agenda for this presentation.
[1:02] So step one in defining the natural history of Rotator Cuff Pathology is to define the prevalence. In 1995 in JBJS.
[1:12] These authors looked at 96 asymptomatic patients and found a prevalence of 20% in asymptomatic people. That is to say that 20% of the people had partial thickness Rotator Cuff tears on MRI scan, and none of these people were symptomatic.
[1:30] If you raise the average age to 60, then you, you will see that the prevalence increases to where 26% of our patients 60 or older will have Rotator Cuff Pathology on MRI scan and not be symptomatic.
[1:46] And what about the, the recurring clinical question of do these partial thickness tears enlarge? Well, there's been many studies looking at this question. In 2015, uh, Jay Keener and Jason Suo looked at the natural history of Rotator Cuff disease and found that 11% of partial tears will enlarge within two years.
[2:08] And that 1 out of 3, approximately will enlarge within 5 years.
[2:12] In 2018, Ian Lowe and some of his partners looked at a very similar question and found that tendon tears less than 50% in thickness will enlarge 14% of the time.
[2:24] If that Partial-thickness rotator cuff tear is greater than 50% of the thickness.
[2:29] They found that it will enlarge over half the time, 55% of the time.
[2:37] In 2017, these authors from South Korea found that 26% of symptomatic partial tears will increase within 19 months. So, to paraphrase that, one out of four patients that have symptomatic partial tears will have their tear increase within a year and a half if you do nothing.
[2:59] The Moon Study Group was a landmark, uh, multi-center study group in 2013, they published this study. They looked at one treatment option for full thickness tears. And so what they found was that Physical therapy was very successful in treating a traumatic or degenerative full-thickness Rotator Cuff tears. They found that patients that completed their therapy had similar outcomes to patients that had Surgery. And again, this is in full thickness tears, not partial tears.
[3:28] Uh, they also found that patients that had intact repaired tendons were stronger than patients that, uh, continued to have tendon defects.
[3:37] Patients that opted for Surgery in this moon study group usually did so within the 1st 3 months of Surgery.
[3:44] So here, we do have a Physical therapy option that works for full thickness tears. We can make the assumption safely, I think that there is a Physical therapy option for partial thickness tears or we could even follow the same protocol and expect similar, if not better results.
[3:59] So in this slide, we're looking at subacromial steroid injections as an option for treating patients with partial thickness Rotator Cuff Pathology.
[4:09] We can see that these subacromial steroid shots may be effective in the very short term, but their effectiveness wears off over time.
[4:18] 27% of the patients in this 2009 study had a duration of benefit of less than 6 weeks. 37% of the patients had Pain relief from six weeks to 6 months. So if you add those two together, over 50% of the time, the duration of Pain relief from a subacromial steroid Injection is less than 6 months.
[4:40] Now this was a retrospective study. Uh, these authors also found that the number of steroid injections did not correlate with increasing Rotator Cuff tears.
[4:49] However, we do know from multiple Other published work that steroid injections can damage collagen structure, steroid injections reduce collagen density.
[4:59] They reduce tenocyte migration.
[5:02] They reduce fibroblast proliferation.
[5:06] And they soften Rotator Cuff tendon. None of these things are um empirically thought to be positive things when we're trying to heal tendons.
[5:16] We also have recent work over the last several years that showed that a single subacromial steroid Injection can lead to an increased risk of surgical infection anytime over the next year after that single Injection. So, so Other than being short-term beneficial for Pain relief, most of the Other effects of steroid injections are catabolic. They're breaking down soft tissues.
[5:41] Finally, we get to an orthobiologic option. Uh, this is a PRP Injection option. And this has been studied in the literature in 2016.
[5:50] Uh, we have authors that looked at 40 patients. They found that PRP was better than steroid injections at 3 months, but that the clinical outcomes were equal at 6 months. Uh, these authors also found no significant differences in MRI scan through the 6 months of the study.
[6:08] Uh, we don't know what type of PRP they use, but I would, I would point out that the, the fact that the results are equal at 6 months does not mean that we should discount this new orthobiologic, uh, intervention with PRP. Somebody getting better faster is clinically significant, in my opinion, even if the long-term outcome is the same.
[6:30] In 2018, we have a level one prospective randomized study, so a, a well-done study with 138 patients.
[6:40] These patients received 4 weekly subacromial injections, and they were followed up for a year. Note that in this study, patients had their PRP combined with sodium hyaluronate.
[6:52] What they found was that patients that had the sodium hyaluronate plus PRP did better at 12 months compared to just the PRP group, and both of those groups did better than placebo or sodium hyaluronate alone.
[7:06] When you look at their PRP, it was a 20 cc blood draw and a two-spin system, and they delivered 4 cc's of what they characterized as leukocyte 4 PRP. When you, when you dissect that information, we're basically looking at what seems to be 3.5X to 4.5X PRP, relatively low volume. Um, but again, positive results out to 1 year.
[7:36] Here's some additional studies looking at the same question. Is there a PRP option for partial thickness Rotator Cuff tears?
[7:44] In 2019, we have a level two meta-analysis where they they looked at five separate level one and level two studies.
[7:52] What they found in summary was that PRP injections may not be beneficial, but I think their last conclusion is the most clinically significant, that that interpretation of the literature, even in these level 1 and 2 studies at the time, was confounded by the lack of reporting of the Cytology and characteristics of the PRP. So, even with a level 1 study, if we're not adequately reporting and characterizing the PRP, it is hard to, to globalize results or to combine results.
[8:20] In 2020, uh, this year, there's been another nice level one study, uh, 99 patients looking at PRP injections versus steroid Injection with three-month follow-up.
[8:31] What they found is that PRP patients had better Pain scores at 3 months.
[8:37] But that their Pain scores are the same at 6 weeks.
[8:40] And they also define PRP failure at one year as needing more treatment or surgical intervention.
[8:47] What is interesting by this um author and authors, uh, based out of Canada, is that the PRP they used was from a company called Virgen Lab. It was their system, which is a 10 cc blood draw from which 5.5 cc's of PRP is made. So, this is um essentially 1.6x PRP.
[9:09] Um, relatively low concentration. And so maybe the take-home message here in this level one study is that even relatively low concentration PRP is at least equivalent to steroid Injection at 3 months.
[9:25] I do want to talk about adipose tissue briefly. Uh, we do have some published literature looking at non-cultured, non-digested adipose injections for partial thickness Rotator Cuff tears.
[9:36] In 2018, uh, Richie Strano and Jerry Maloga and some others, um, uh, published a level 3 study. They looked at 18 patients, at least 6 of which had full thickness tears, so it's a little bit of a mix of group. Uh, they used the LipoGym system, and what they found at one-year follow-up was that the adipose patients, the LipoGym's treated patients had better American Shoulder and elbow scores at 6 months and 1 year, that these patients maintained 50% decrease in Pain at 1 year.
[10:06] And that the ASCS scores were 100% better at one year, from 34 up to 69.
[10:12] They did not have imaging results post procedure, but this is a nice study, um, essentially a pilot study showing that Lipogem's type of treatment for these partial thickness cuff tears and even some full thickness cuff tears can give patients durable Pain relief out to a year.
[10:28] In 2020, we have a level one pilot study.
[10:32] Using a different adipose system. This is the transpose uh Matras system. Uh, there were 15 patients in this study, and the adipose treated patients had better ASCS scores at 6 months and 1 year. Uh, this is a, again, a pilot study, so we don't have statistically significant data, but it does show that it was a safe intervention, uh, with potential, um, uh, clinical benefit.
[10:59] What about some of the Other uh birth tissue Orthobiologics and exosomes? Uh, so, we're talking here about amniotic fluid, umbilical cord blood, exosomes. Well, we have no significant human outcome studies using these products alone for partial thickness Rotator Cuff tears. And on top of that, we have significant FDA documentation that these products are misbranded and not appropriately registered with the FDA under a, a pure section 361 designation.
[11:26] So, in a word, no. These are not appropriate for partial thickness Rotator Cuff tears without further regulatory uh clearance, um, or in my opinion, without any human outcome data, without safety data, without significant animal data, and certainly with no human clinical data.
[11:45] What about Bone Marrow injections for partial thickness Rotator Cuff tears? So, this is not Bone Marrow Concentrate, but just Bone Marrow. So, um, the most, um, um, talked about device on the market that, that this would be, um, uh, appropriate to consider would be the, the marrow solutions type needles shown on the left. Uh, those prices are prices I've seen in the Dallas-Fort Worth area, including at our hospital. And, uh, the issue with using Bone Marrow aspirate alone is that we don't have any human outcome studies.
[12:14] This is not Bone Marrow Concentrate. It is not the same orthobiologic. It is not the same as cultured Bone Marrow stem cells, and therefore, it needs its own set of safety data and human outcomes data to validate it as an appropriate orthobiologic. So, so far, we don't have any studies. So that's why this is uh in the Journal of None.
[12:36] What about Bone Marrow Concentrate injections? Well, we do have some studies, including uh the subject of this talk, talking about Bone Marrow Concentrate injections for partial thickness Rotator Cuff tears. Uh, this study published in 2018 by some South Korean researchers, again, uh, shows the device they used on the left. This is an appearance by Ultrasound showing, um, the types of partial thickness tears that they were treating, which looks certainly appropriate.
[13:03] This is a small study with 12 patients in, in therapy and 12 patients treated with an Injection. At 3 months, which is relatively short follow-up, but at 3 months, the Pain scores were better and the Americanhouler and Elbow scores were better, and the Bone Marrow aspirate uh concentrate group. There was no significant difference in tear size at 3 months.
[13:24] So this type of small study is the type of study that with with early preliminary positive results, hopefully, hopefully leads to larger studies and refinement of the clinical technique.
[13:36] This study published in 2020 by Cri Centino and colleagues um out of the Regenic Network was a randomized controlled trial of the treatment of Rotator Cuff tears with Bone Marrow Concentrate and platelet products. So, not a pure uh study on Bone Marrow Concentrate because they also use PRP and platelet lysate, but it is a nice study um to be able to refer to when counseling patients on potential expectations from this treatment.
[14:03] Uh, they treated 14 patients with Injection and had 11 patients in Physical therapy. One of the confounding factors is that 10 of the 11 Physical therapy patients crossed into the BMC group.
[14:15] And in the BMC injectate, they quantified that as being 60% BMC, 20% PRP, and 20% platelet lysate. And this was injected directly into the tendon.
[14:27] Uh, they followed these patients up for a year, and they found that the DASH scores significantly improved up to the 1-year time interval. They also did some imaging and noted the tear size decreased 26% at 1 year.
[14:41] In their analysis of some of the cellular data, they found that the total nucleated cell count did not correlate with the clinical outcome from the Injection. And they did find that their total nucleated cell count from their BMC technique averaged 810 million.
[15:00] So let's talk about the final, the final answer as a surgeon, which would be, you know, steel and scissors and knives and scalpels and sharp things. So, what is the surgical outcome? It's important in counseling patients to have accurate recent data because the data does sometimes change.
[15:17] And so, in this 2009 study in JBJS uh from well-published authors and, and thoughtful, um, surgical uh clinicians,
[15:27] 41 patients had tendon tears converted to full thickness tears and then subsequently repaired arthroscopically.
[15:35] And what Ken and his partners found was that 88% of these Rotator Cuff repairs were intact at 11 months, and the patient's satisfaction was 93%. And so again, this is a technique where the partial tear is completed to a small full thickness tear, repaired, and then patients are followed under a um a full thickness uh repair protocol postoperatively.
[16:00] There's another study in 2018, uh, done by some, some, uh, again, some thoughtful, um, educators, Mark Gettleman, Ron Karzel, uh, Brian, and, and, and, um,
[16:12] Doctor Lee, um, this is a full thickness Rotator Cuff study.
[16:18] So, it's even beyond the Partial-thickness rotator cuff tear. The reason why I wanted to highlight this study is because you see what's in red here. These authors do believe in Orthobiologics. They believe that it's important to make Bone Marrow vents. Why is that important? It's important because that's where the mosa.
[16:34] Amal stem cells are, that's where the growth factors are. And so this is essentially a poor man's BMC. If we make some holes in the, in the greater tuberosity at the end of the procedure, that has been shown to have a positive clinical effect on outcomes and on healing. And so in this study, 52 patients with full thickness tears, 2 to 4 centimeters, were repaired using a single row.
[16:57] And what they found at 2 years, so this is a year longer than the prior study, was that 91% of these repairs are intact at 2 years. Also, I think what's important to counsel patients is that if you have an intact Rotator Cuff, you will have better Shoulder function.
[17:13] Particularly in terms of strength, than if you have a hole in your Rotator Cuff. And, and uh Mark uh Gettleman and Ron Karzel found that in this study.
[17:23] So, the Bone Marrow bits, I think, are uh the very least that I can do surgically to try and create a biologic stimulus. What we're trying to do is capture that, really, um, supercharge it by making Bone Marrow Concentrate and then delivering that into these partial thickness tears. So that gets into the surgical downtime, which is one of the reasons why we're looking for an In-Office solution.
[17:47] These are basically the three phases of surgical rehab.
[17:56] So these are our study questions in 2016. Can a single Injection of iliac crest Bone Marrow Concentrate promote healing, decrease Pain, and improve function along with decreasing the downtime in patients with partial thickness Rotator Cuff tears?
[18:11] And our second big study question was can an In-Office single-site ultrasound-guided iliac crest aspiration provide BMC similar to BMC and Other published studies. We want to make sure that our BMC harvesting protocol is on par with everyone else's, basically.
[18:27] And so our aspiration protocol, it's an In-Office ultrasound-guided posterior iliac crest aspiration. It is a single cortical site with multiple depths. We use 10 cc syringes because that's been shown to be beneficial in, in retrieving a higher cell count. We use a jam sheety multi-port needle because no one's ever shown any need um to use uh something more expensive or something more complicated than that if the rest of these um aspiration protocol um techniques are followed.
[18:58] For this study, we were sponsored by Selling Biosciences. They donated their ARC BMC device, which is a device that, that takes 50 to 60 cc's of Bone Marrow aspirate, and then in a single spin, creates a buffy coat that we then use to make um um to create the BMC Injection.
[19:16] Uh, selling Biosciences also sponsored our cellular analysis, where we looked at the Bone Marrow Concentrate from all 25 patients, and in 15 of those patients are also able to have matching Bone Marrow aspirate evaluation.
[19:28] Our clinical evaluation included MRI scans at 6 months and 1 year to assess tear propagation or to, to show healing.
[19:36] Our patient scores were the American Shoulder and Elbow score, the patient self-reported SANE score, the Single assessment numeric score, and the patient Pain scores, the NPS.
[19:50] This is our study design. Patients were not charged to be in the study. Insurance companies are not billed for the patients that were studied.
[20:00] The doctors were not paid, and there was no study fee um to anybody to be in the study.
[20:07] I found 3 people who were interested that were far smarter than me. And so I want to thank Matt Murphy, uh, Richard Suzuki, and Jazon Gao. They were a true PhD dream team, and they helped, uh, validate the study protocol and evaluate the cellular data and make sure that we were doing things in a thoughtful way. Uh, this was a pilot study designed with 25 patients enrolled. This was prospective, but it was not blinded.
[20:32] And our only cohort was a historical cohort based on natural history studies. We did not have a, a blinded, uh, study group or an alternative study cohort.
[20:45] One of the first things we had to do is decide how we were going to get this, uh, Bone Marrow. So we used an ultrasound-guided posterior iliac crest aspiration technique. We call that UPICA for short. That's been separately validated. Um, if you look at the CT scan here on the top right, we basically go in the posteriiliac crest because there's more bone around that red line posteriorly than there is anteriorly.
[21:11] It's a much safer procedure. And there's several Other reasons why going posterior makes more sense in my opinion. The Other is we're not um having the patient supine, but the patient can be prone, which usually means they're more comfortable, and, and they're not watching us do the procedure, which usually leads to more comfort and less Pain for them.
[21:30] Oh, it's very easy to get an Ultrasound image of the posterior iliac crest. We mark the site with a 22 gauge needle. We use local anesthesia from the cortex through all of the, uh, soft tissue fields up to the skin.
[21:43] We leave the spinal needle in so that we no longer need Ultrasound after the initial identification of the PSIS. We wait 4 to 5 minutes for the local anesthetic to take effect.
[21:54] And then we go ahead and proceed with our, our harvest.
[21:57] The full details are found at this website. You can go to Buford.info/Uaika, and the aspiration protocol is available for free there.
[22:09] One of the important things in maximizing our cell count is to use smaller syringes. So we used 10 cc syringes. We also took care not to aspirate the full volume of 10 cc's just to try and fine tune um our maximization of, of cell recovery.
[22:28] In every syringe, we use 1 cc approximately of heparin flush. Um, the volume of heparin flush overall didn't matter. What does matter is the concentration. And so if you make 15 cc's of heparin flush with normal saline, you want to make sure that it's 2000 units per cc. In a similar fashion, if you're, if you're using 30 cc's of normal saline, you want to put in 60,000 cc's of heparin to maintain that 2000 units per cc concentration. In doing that, we haven't found clotting to be an issue.
[22:58] The rest of our protocol involves harvesting two times at each level. Because this is a multi-port needle, and the ports are 90 degrees, or I'm sorry, 180 degrees opposite each Other, we turn the needle 90 degrees in between aspirating at each level. That allows us to aspirate from the entire 360 degree field at each level.
[23:19] Notice that the needle is no longer a $600 to $2500 needle. This is a $20 readily available jamshidi. It's an 11 gauge multiport needle with a diamond bezel.
[23:31] After harvesting 2 times at each level, we take the needle 10 centimeter deeper manually, and we go from superficial to deep because we feel that's the safest way to do it without having fluoroscopy in the room.
[23:47] We repeat the process of two aspirations per level until we have the desired volume of Bone Marrow aspirates. So typically, that would be uh 3 to 4 levels. Uh, it's uh well within the safety zone in the posteriiliac crest. We typically never go deeper than 3.5 or at most 4 centimeters deep.
[24:08] We filtered the aspirate. In our study protocol, we sent off 1 cc of the Bone Marrow aspirate to the lab. We then loaded the selling Biosciences device.
[24:19] We then did a single spin for their protocol of 15 minutes, which allowed us to create a buffy coat to uh to, to recover the Bone Marrow Concentrate.
[24:30] From the Bone Marrow Concentrate 15 cc was sent to the lab to analyze the BMC for comparison.
[24:38] We had 0 infections, we had 0 fractures, and no neurovascular injuries. Not only in the study of 25, but we've not had any of these complications over the many years of, of, of doing this. So over the 78, maybe even 9 years now of doing um this procedure in the office, we've had none of these complications.
[24:58] Here's a nice slide showing the cellular analysis that my PhD dream team put together. The average cell viability was 97.5%.
[25:09] When we compared this to another published study, uh, we found that our total nucleated cell count and CFU counts were comparable. Uh, you have to remember that comparing CFU counts across labs on different days is really not appropriate. So we were just looking for a baseline to show that we had, at least in the literature, something comparable, that we weren't an order of magnitude off in our CFUs or in our total nucleated cell counts.
[25:35] The Other thing that I think was important to show is that concentrating Bone Marrow aspirate matters. We were able to concentrate sixfold. We were able to raise our Stem Cell count from 870 to 4907 per cc, and that is a significant increase that you can only achieve with concentrating. There is no aspiration technique that's going to concentrate CFUs greater than sixfold like you can by concentrating uh with the centrifuge-based system.
[26:04] This is an example of how we injected these partial tears. Here you can see the injectate going in and traveling through the partially torn supraspinatus tendon.
[26:16] OK, so let's look at the results.
[26:20] We were able to treat 25 patients and the last patient was treated August 2018.
[26:26] 15 patients were treated.
[26:28] That had Bone Marrow aspirate and Bone Marrow Concentrate cellular analysis, so we had matched samples.
[26:35] All 25 patients did have Bone Marrow Concentrate cellular analysis.
[26:39] Our average age was 53 years. There was a slight male predominance in gender. Uh, the tear size ranged from really from 25% up to about 85%.
[26:52] These are our numeric Pain scale results. Our pre-procedure NPS averaged 6.3.
[26:59] By 3 months that had dropped to 3.7.
[27:02] At one year, our average NPS from a single Injection was 1.7, and that result was durable out to two years with an NPS at 2 years of 1.8.
[27:15] Our SANE score results were very similar. Three months post procedure, our SANE score averaged 61.25. At six months, patients self-reported about a 74% improvement.
[27:29] At one year, patients self-reported about an 85 to 86% improvement. And at 2 years, they were still reporting about an 84% improvement over their pre-procedure, um, uh, status from a single Injection of Bone Marrow Concentrate.
[27:47] Our ASES scores also documented a functional improvement that was durable out to 2 years. The pre-procedure ASES averaged 49.6.
[28:00] By 3 months, the average ASCS had increased to 62.2.
[28:06] At one year, the average ASCS score was 77.7, and at two years, it was 79.9. So as you can see, there was a nice consistent increase in functional improvement that was durable through two years. So I'm putting this all together, the question truly is, are we impacting the natural history of symptomatic partial thickness Rotator Cuff tears?
[28:27] We have referenced publications in 2017, in which 26% of the patients with symptomatic partial cuff tears had an increase in size of the tear over 19 months.
[28:39] I think that our study shows that we are positively impacting the natural history of these partial thickness cuff tears that are symptomatic. When you put together our results, 56% of the patients either had no significant change in tear size or had a tear reduction.
[28:55] We did have approximately the same percentage, 28% that had tear progression in the 12 months um uh over which we had imaging.
[29:05] So highlights, our Ultrasound guided In-Office single cortical stick, multi-deep, posteriiliac crest poma aspiration can be safely done. It can provide quality BMC at least equivalent to what's been reported in the literature.
[29:20] At least a 50% reduction in Pain by 3 months and 44% of our patients.
[29:26] I think the big thing that we use to counsel our patients at this point is this next line, that at least a 50% Pain reduction at one year can be expected in 80% of our patients.
[29:38] Our patients self-reported an average of an 86% improvement at one year, and this was maintained through two years.
[29:48] The average ASCS score increased from 49.6 to 76.3 at six months. So we use that to tell patients that we can hope for a 50% improvement in their function, um, at the six-month mark. And that that improvement should be maintained for 2 years in 80% of the patients.
[30:06] We do tell patients that we do not expect their MRI scans to get smaller, that in 56% of our patients, the MRI scans stayed the same or got marginally smaller.
[30:16] The average tear progression was 28% of our patients in our study. Tear progression did not equal surgical um outcomes. Tear progression, um, often did not equal poor functional outcome either in this study.
[30:32] Thank you for your attention and we'll be happy to answer any questions and have nice uh discussion in the Q&A section after the talk. Thank you.